S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: chemotherapy

Registration Number: NCT00382018

Lead Sponsor: SWOG Cancer Research Network

Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are high while receiving chemotherapy, it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression.

PURPOSE: This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.

Detailed Description: OBJECTIVES:

Primary

* Determine whether women with metastatic breast cancer and elevated circulating tumor cells (CTCs) (≥ 5 per 7.5 mL of whole blood) after 3 weeks of first-line chemotherapy derive increased overall survival from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen.

* Determine whether these patients derive increased progression-free survival (PFS) from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen.

* Confirm previous findings that patients with \< 5 CTCs per 7.5 mL of whole blood on initial screening have longer median OS and PFS than patients with ≥ 5 CTCs per 7.5 mL of whole blood.

* Determine the prognostic value of sequentially collected CTC values in these patients.

* Compare toxicity between patients with and without elevated CTCs after 3 weeks of first-line chemotherapy AND between the two randomized treatment arms.

Secondary

* Compare the prognostic and predictive value of CTC number vs breast cancer tumor markers, including CA 15-3 and carcinoembryonic antigen.

* Create a serum specimen bank for future biologic investigation.

OUTLINE: This is a partially blinded, partially randomized, multicenter study. Patients are assigned to 1 of 3 groups based on circulating tumor cells (CTCs) after 1 course of chemotherapy.

All patients undergo blood collection before their first dose of first-line chemotherapy\* to determine baseline CTC count. Patients with \< 5 CTCs at baseline are assigned to group I. Patients with ≥ 5 CTCs at baseline undergo a second blood draw on day 22 (after completion of 1 course of chemotherapy). Patients with \< 5 CTCs after completing 1 course of chemotherapy are assigned to group 2. Patients with ≥ 5 CTCs after completion of 1 course of chemotherapy are assigned to group 3.

NOTE: \*Chemotherapy may be initiated while waiting for the baseline CTC result.

* Group 1 (low risk of early progression): Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected.

* Group 2 (moderate risk of early progression): Patients continue to receive their current chemotherapy regimen without change.

* Group 3 (high risk of early progression): Patients are stratified according to HER-2 status (positive vs negative) and disease type (bone-only vs measurable disease). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients continue with their current chemotherapy regimen without change.

* Arm II: Patients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor.

Patients receiving hormonal therapy or biologic therapy and chemotherapy continue to receive the hormonal or biologic therapy unchanged regardless of CTC level.

In groups 2 and 3, blood is collected periodically during chemotherapy and then at the completion of chemotherapy. Samples are examined for CTCs via the CellSearch™ blood test. Blood is also tested for CA 15-3 and carcinoembryonic antigen (CEA).

After completion of study therapy, patients are followed for up to 5 years.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 624

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	chemotherapy	Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected.
Group 3, Arm I	chemotherapy	Patients continue with their current chemotherapy regimen without change.
Group 3, Arm II	chemotherapy	Patients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor.
Group 2	chemotherapy	Patients continue to receive their current chemotherapy regimen without change.

Primary Outcome Measures

Name	Time	Method
Overall Survival	Every 3 months until progression then every 6 months for 5 years or until death	From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Progression-free Survival	every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Progression Free Survival	every 3 months until progression	From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events That Are Related to Study Drugs	Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression	Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Trial Locations

Locations (295): Regional Medical Center
🇺🇸
Anniston, Alabama, United States
Alaska Regional Hospital Cancer Center
🇺🇸
Anchorage, Alaska, United States
Providence Cancer Center
🇺🇸
Anchorage, Alaska, United States
NEA Medical Center - Stadium Boulevard
🇺🇸
Jonesboro, Arkansas, United States
Glendale Memorial Hospital Comprehensive Cancer Center
🇺🇸
Glendale, California, United States
California Cancer Care, Incorporated - Greenbrae
🇺🇸
Greenbrae, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸
Loma Linda, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Camino Medical Group - Treatment Center
🇺🇸
Mountain View, California, United States
Palo Alto Medical Foundation
🇺🇸
Palo Alto, California, United States
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Regional Medical Center
🇺🇸Anniston, Alabama, United States